Dry Eye
Conditions
Keywords
cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
Brief summary
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
Detailed description
Single-center, prospective, randomized, investigator-initiated study 250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
Interventions
BID OU
Sponsors
Bucci Laser Vision Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
Exclusion criteria
* Negative Inflammadry assay in either eye * Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation * Ocular surface diseases that might confound the interpretation of the InflammaDry assay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra | 12 weeks | Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra |
Countries
United States
Outcome results
None listed